To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts.
- Understanding And Navigating Diverse Regulatory Environments
- A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies
- Is WuXi AppTec An Enemy Of The State?
- Developing & Implementing A Continuous Bioprocess Control Strategy
- Why Are Cell-Therapy Outsourcers Unhappy? Investors Know
- Huh? Where Did That Environmental Monitoring Hit Come From?
- A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis
Understanding And Navigating Diverse Regulatory Environments
Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.
A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies
Establishing a robust contamination control strategy for advanced therapy medicinal products, also referred to as cellular and gene therapy products, is of utmost importance. We must employ risk assessments and risk-based approaches. In this article, the authors introduce the aseptic risk evaluation model (AREM), which is compliant with the evolving global regulatory landscape and best practices.
Developing & Implementing A Continuous Bioprocess Control Strategy
A key challenge to better uptake of continuous processes in biologics manufacturing is the necessity to link unit operations. This article defines a standard template approach for developing and implementing a continuous bioprocessing control strategy, providing a visual and technical aid, and sharing considerations when selecting control schemes.
Huh? Where Did That Environmental Monitoring Hit Come From?
After decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid.
A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis
The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. This article will provide a detailed discussion of how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can be used for guiding the selection of risk reduction and risk control measures.
FDA’s CBER Issues Final Guidance For CAR T Cell Products
The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on January 29. This article shares a useful and thorough summary of the guidance and where it differs (or not) from the earlier draft version of the guidance.
New DSCSA Guidance Details Layers Of Verification System Requirements
A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear.
Using Relational Risk Analysis To Control Procedure Failures In The Bio/Pharma & Medical Device Industry
In the bio/pharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).
PHARMA OUTSOURCING WHITE PAPERS
GMP-Validated Adventitious Virus Testing By Next Generation Sequencing
Gain required knowledge related to the involved regulatory authorities and scientific technologies and disciplines: Next Generation Sequencing (NGS), Bioinformatics and Computer System Validation (CSV).
Regulatory Considerations For Alternative Microbial Methods
We discuss regulatory expectations for the incorporation of alternative methods to prevent, remove, and detect contaminants focusing on comparability and strategies for easier substitution of current methods.
Trends In The Outsourcing Of Development And Manufacturing Of Biologics
Read more on trends related to outsourcing and share what attributes of an outsourcing partner are sought by developers and manufacturers of biopharmaceuticals.
The MAPPs Assay: A Useful Tool For The Assessment Of Immunogenicity
Explore how MAPPS demonstrates promise as a valuable tool for comprehensive immunogenicity assessment in therapeutic protein development, contributing to safer and more effective biologics.
β-Glucan As A Process-Related Impurity In Biopharmaceuticals
In this white paper, we dig deeper into the sources of β-glucan, its influence on manufacturing and patient safety, and ways to detect and control its amounts in the finished drug product.
Liposomal And Nanoparticle Technology
Specializing in oncology, anti-infective and complex formulations, the facility provides end-to-end services from development through to commercial manufacture of sterile dosage forms.
They say biotech taught pharma how to outsource. So what’s someone who has spent 31 years working in Big Pharma know about outsourcing from the vantage point of smaller organizations? A lot, it turns out. In this latest e-book, Chief Editor, Louis Garguilo sits down with Francis Dumont just after he retired from Pfizer for an in-depth conversation on drug development and manufacturing outsourcing.More Content Collections